modafinil

Generic: modafinil

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name modafinil
Generic Name modafinil
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

modafinil 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6791
Product ID 0904-6791_9b081f9e-c042-4aa8-833a-0701015ab9a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077667
DEA Schedule civ
Listing Expiration 2026-12-31
Marketing Start 2014-02-03

Pharmacologic Class

Established (EPC)
sympathomimetic-like agent [epc]
Physiologic Effect
central nervous system stimulation [pe] increased sympathetic activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046791
Hyphenated Format 0904-6791

Supplemental Identifiers

RxCUI
205324 260218
UNII
R3UK8X3U3D
NUI
N0000175729 N0000175651 N0000175769

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name modafinil (source: ndc)
Generic Name modafinil (source: ndc)
Application Number ANDA077667 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6791-04) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6791-04 30 BLISTER PACK in 1 CARTON (0904-6791-04) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

modafinil (100 mg/1)

Linked Drug Pages (1)

Modafinil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9b081f9e-c042-4aa8-833a-0701015ab9a4", "openfda": {"nui": ["N0000175729", "N0000175651", "N0000175769"], "unii": ["R3UK8X3U3D"], "rxcui": ["205324", "260218"], "spl_set_id": ["4a7ab52b-db31-4774-a06a-b11f2bb60662"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]"], "pharm_class_epc": ["Sympathomimetic-like Agent [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6791-04)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6791-04", "marketing_start_date": "20140203"}], "brand_name": "Modafinil", "product_id": "0904-6791_9b081f9e-c042-4aa8-833a-0701015ab9a4", "dosage_form": "TABLET", "pharm_class": ["Central Nervous System Stimulation [PE]", "Increased Sympathetic Activity [PE]", "Sympathomimetic-like Agent [EPC]"], "product_ndc": "0904-6791", "dea_schedule": "CIV", "generic_name": "modafinil", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Modafinil", "active_ingredients": [{"name": "MODAFINIL", "strength": "100 mg/1"}], "application_number": "ANDA077667", "marketing_category": "ANDA", "marketing_start_date": "20140203", "listing_expiration_date": "20261231"}